Basic Information
Saxenda
Regulatory Information
EMEA/H/C/003780
March 23, 2015
January 22, 2015
17
February 20, 2025
Company Information
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of • ≥ 30 kg/m² (obese), or • ≥ 27 kg/m² to < 30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea. Treatment with Saxenda should be discontinued after 12 weeks on the 3.0 mg/day dose if patients have not lost at least 5% of their initial body weight. Adolescents (≥12 years) Saxenda can be used as an adjunct to a healthy nutrition and increased physical activity for weight management in adolescent patients from the age of 12 years and above with: - obesity (BMI corresponding to ≥30 kg/m2 for adults by international cut-off points)\* and - body weight above 60 kg. Treatment with Saxenda should be discontinued and re-evaluated if patients have not lost at least 4% of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or maximum tolerated dose.
Overview Summary
Saxenda is a medicine used along with diet and increased physical activity to help manage weight in: - adults who have obesity (BMI of 30 or more); - adults who are overweight (BMI between 27 and 30) and have weight-related complications such as diabetes, abnormally high levels of fat in the blood, high blood pressure or obstructive sleep apnoea (frequent interruption of breathing during sleep). - adolescents from 12 years of age with obesity (BMI of 30 or more) who weigh more than 60 kg. BMI (body mass index) is a measure of your weight in relation to your height. Saxenda contains the active substance liraglutide.